Carbon Monoxide Breath Sensor

GUDID 00863571000301

CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.

Carbon monoxide breath analyser
Primary Device ID00863571000301
NIH Device Record Key0c7b71fd-2c30-4d31-9cfe-04fa087f8b8d
Commercial Distribution Discontinuation2019-04-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCarbon Monoxide Breath Sensor
Version Model NumberFP-20021
Company DUNS080137777
Company NameCARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-855-374-7727
Emailsupport@pivot.co

Device Identifiers

Device Issuing AgencyDevice ID
GS100863571000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-17
Device Publish Date2017-10-27

On-Brand Devices [Carbon Monoxide Breath Sensor ]

08635710003007FP-20021
00863571000301FP-20021

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